1. Field of the Invention
The present invention provides topical compositions and methods for the treatment, removal, elimination and prevention of seborrheic keratoses. More specifically, the present invention involves the use of high concentration hydrogen peroxide to treat the affliction.
2. Description of Related Art
Seborrheic keratoses are the most common benign lesions observed in humans. According to the U.S. National Health and Nutrition Examination Survey of 1995–1996, about 45 million persons in the United States have seborrheic keratoses with the distribution being about equal between the sexes. Seborrheic keratoses were described as early as 1864 by Virchow and in 1869 by Neumann, who called them senile warts. Seborrheic keratoses have also been described as senile verruca, pigmented verruca, keratosis pigmentosa, basal cell papilloma and a long list of other names in the medical literature.
Seborrheic keratoses may take a variety of forms, including but not limited to: dermatosis papulosa nigra, stucco, acanthotic, hyperkeratotic, dermatolipoma, verrucous, melanoacanthotic, reticular, adenoid, and clonal.
In general, seborrheic keratoses begin as small, round or oval, brownish macules. The sites of predilection are the face, scalp, trunk, particularly the interscapular and sternal regions and the backs of the hands. In rare cases, seborrheic keratoses have also been reported in the ear canal and the penis. Seborrheic keratoses do not occur on the palms of the hands or soles of the feet.
All lesions of seborrheic keratosis, whether small or large, show a sharp line of demarcation between the pathologic changes seen in the tumor and the normal adjacent skin.
In a small seborrheic keratosis, the epidermis at the border shows an abrupt elevation to produce many finger-like upward projections, each of which contains a central core of connective tissue. These digitations are covered by a loose non-nucleated scale which dips down to fill all of the intervening crevices and which forms a thick plug in each of the follicles.
As the keratosis grows larger the digitations elongate and they show an irregular cellular hyperplasia to produce anastomoses in many directions. This acanthosis results in the production of filiform branches and large epidermal masses and many intervening passages which are filled by extensions from the surface scale. In most cases, the granular layer is intact and there are no nuclei in the scale, but occasionally there are a few islands of parakeratosis. The basal layer is unbroken and the entire tumor lies superficial to a base that is level with that of the adjacent normal skin.
Seborrheic keratoses may grow to become quite large as illustrated by the report of the giant pedunculated seborrheic keratosis by Dr. Rudolf L. Baer. The patient was reported at the Department of Dermatology at the New York University School of Medicine, in the May 1979 issue of the Archives of Dermatology. The brown-ish lesion developed on the right inguinal region of a 75 year old woman and was allowed to grow for 40 years because of the lack of a convenient treatment such as the present invention for seborrheic keratosis elimination. The seborrheic keratosis, over a period of many years, gradually became larger, and eventually formed a pendulous mass measuring 5.5×3.5 centimeters. Due to the lack of an effective topical treatment such as the present invention, Dr. Baer had to remove the seborrheic keratosis with a scalpel while the patient was under local anesthesia with lidocaine and stop the bleeding by electrodesiccation. Microscopic examination of the gargantuan seborrheic keratosis revealed epidermal hyperplasia with horn pseudocysts, interweaving of the rete, and nuclei of uniform size and shape.
If left untreated, as the vast majority of seborrheic keratoses are, squamous cell carcinoma may arise as reported by Dr. Rudolf L. Baer in the November 1981 issue of the Journal of the American Academy of Dermatology. For some years, due to the lack of an effective self-applied treatment, a 73-year-old patient had allowed a seborrheic keratosis to grow on the left side of his trunk. Some months before consulting Dr. Baer, part of the growth fell off and then recurred with distinctly more elevation than the remainder of the seborrheic keratosis. The seborrheic keratosis was described as a verrucous, keratotic, gray-brown-black, sharply defined lesion with somewhat scalloped edges. The seborrheic keratosis measured 60×27 millimeters and was elevated about 3 mm above the surrounding normal skin. Two different components were within the seborrheic keratosis, one somewhat lighter and less elevated, slightly verrucous area and the second a lighter gray-brown 19×18 millimeter cauliflower-like area, elevated 9 millimeters above the surrounding normal skin. Treatment with the present invention would have prevented the emergence of the squamous cell carcinoma and eliminated the necessity of the lesion being excised with a surrounding margin of normal skin.
Multiple seborrheic keratosis treatment is not readily accomplished by techniques available in conventional practice; therefore, many people suffering with large numbers of seborrheic keratoses go many years with no treatment. Such is the case reported by Dr. Robert W. Cashmore and Dr. Harold O. Perry in the July, 1985 issue of Geriatrics. A 55-year-old Caucasian man had many, many darkly pigmented seborrheic keratoses on his trunk for twenty years. During the twenty years, he was seen for various medical problems, including and anxiety-tension state and preoccupation with bodily functions. During this period, he was seen eight times by a dermatologist for reassurance to alleviate his concern about the multiple seborrheic keratoses. At his last visit, a 1×2 centimeter erythematous lesion was noted among the numerous keratoses on his right shoulder, and this was thought clinically to be a superficial basal cell carcinoma. This impression was confirmed by biopsy. The fact that the man was untreated for twenty years after being examined eight times by a dermatologist and then allowed to develop cancer clearly points to the urgent need for an effective, practical treatment such as the present invention.
Early medical treatment modalities of seborrheic keratoses do not differ appreciably from the treatment choices offered by the majority of present day, medical practitioners with the exception of laser usage for seborrheic keratosis removal, which also results in adverse side effects such as scarring, hyperpigmentation and hypopigmentation.
The Jan. 30, 1915 issue of The Journal of the American Medical Association includes a report titled “The Symptomatology and Treatment of Seborrheic Keratoses” by the prominent Kansas City, Mo. physician Richard L. Sutton. A form of cryogenic therapy is described by Dr. Sutton using Pusey's carbon dioxide snow and a 5 percent ammoniated mercurial ointment. For seborrheic keratoses that have become malignant, Dr. Sutton recommends radical excision. Radium and Roentgen rays are the treatment of choice on the face in the nasal and orbital regions. If Dr. Sutton would have had access to the present invention, his toxic methods utilizing mercury would not have been necessary.
High-frequency electrosurgery has provided dermatology and other areas of medicine with an efficient means of tissue destruction and hemostatis which has been used for seborrheic keratosis removal. When electrosurgery is used for seborrheic keratosis removal, little attention is given to risks of contamination. Indirect contamination can occur as a result of the aerosolization of blood droplets secondary to mechanical actions at the high-frequency electrosurgery site. Hepatitis B or human immunodeficiency disease might be spread through aerosolized microdroplets of blood and electrosurgical smoke.
Electrocoagulation incorporates the patient himself into the electrical circuit with the use of a dispersive electrode plate. This dispersive electrode plate allows the machine to deliver a larger amount of current to the patient. Electrocoagulation occurs when electrosurgical current is applied to the tissue with resistance (ohmic) heat production that cooks tissue. The cooked tissue produces aerosolized microdroplets of blood and electrosurgical smoke. The mechanical action of electrosurgical current entering tissue can give rise to very small blood droplets that can travel a great distance. These droplets get scattered all about the surgical field. Of further concern is the problem of the microdroplets that cannot be seen but may be inhaled or received through the conjunctival surfaces.
Electrodesiccation is the superficial dehydration of tissue as a result of the passage of high-frequency current which leads to scarring and hypopigmentation in some treatments of seborrheic keratosis removal.
Every medical practitioner and dermatologist who practices high-frequency electrosurgery should provide surgical masks and eye protection to everyone in the premises and sterilize all exposed surfaces.
The smoke generated by laser surgery is capable of carrying viable viral particles. Seborrheic keratosis elimination attempts with various lasers commonly used in dermatology such as the carbon dioxide, erbium:YAG, and ND:YAG have been so disappointing that the treatment often leaves a worse cosmetic result than the seborrheic keratosis consisted of.
Cryosurgery of seborrheic keratoses with liquid nitrogen and carbon dioxide has been found to cause dischromic patches due to freezing of the skin surrounding the margin of the lesion. Recovery of the patient takes up to three weeks versus no recovery time using the present invention.
Seborrheic keratoses are the leading cause of visits to dermatologists according to Henry H. Roenigk, Jr. M. D., a leading dermatologist with the Mayo Clinic in Scottsdale, Ariz. Dr. Roenigk generally discourages seborrheic keratosis treatment of any type unless trauma or malignancy of the seborrheic keratosis is present.
Medical practitioners such as dermatologists, plastic surgeons and general practitioners are extremely reluctant to treat facial seborrheic keratoses with current methods because of the high incidence of lawsuits due to unsatisfactory results such as scarring, hyperpigmentation and hypopigmentation.
Twenty five dermatologists and medical doctors in metropolitan practice were surveyed as to seborrheic keratosis removal method, side effects, pricing, insurance reimbursement, and appointment lead time. Fifty-two percent of the dermatologists surveyed used the inject, cut, burn, and bandage method of seborrheic keratosis removal with no form of seborrheic keratosis prevention. All of the dermatologists and medical doctors surveyed reported scarring after their particular type of treatment. None of the dermatologists or medical doctors surveyed reported using any type of topical treatment, clearly pointing to the need for the present invention of seborrheic keratosis elimination.